Human Medicines Regulations 2012 C

What must manufacturers do under HMR 2012?

• Manufacture medicines that comply with the marketing authorisation

• Maintain and demonstrate quality standards

• Label products to a specified standard

• Provide patient information leaflets with their products

What sort of licenses exist under the regulation?

• Marketing Authorisation

• Manufacturers Licence

• Product licence (parallel importing)

• Wholesale dealing licence

What was a Marketing Authorisation previously called?

A product licence

What factors must the MHRA consider prior to issuing a Marketing Authorisation (MA)?

• Safety

• Efficacy

• Quality

What activities require a Manufacturer’s/Importer’s Licence (MIA)?

• Manufacturing medicinal products

• Packaging medicinal products

• Importing licensed medicines into Great Britain from outside the UK by wholesale

What factors are assessed when issuing an MIA?

• Premises

• Equipment

• Skills and qualifications of staff

• Storage conditions

What is a parallel import licence (PLPI)?

A licence issued by the MHRA allowing the importation of a medicine already authorised in the UK and another country.

What conditions must be met for a PLPI?

Must have a UK MA and a marketing authorisation from the exporting country

What categories are PLPI divided into?

• Simple

• Standard

• Complex

What does an MIA cover as opposed to a PLPI?

MIA covers the company or site, focusing on facilities, staff and processes whereas PLPI covers a specific medicine

What is an MIA needed for as opposed to a PLPI?

MIA is required to manufacture, assemble, package or import medicines while a PLPI is required to import and re-label a product with a foreign MA that matches a UK MA.

What is a Manufacturer ‘Specials’ Licence?

A licence allowing the manufacture or import of unlicensed medicinal products (“specials”)

Which standards must ‘specials’ manufacturers comply with?

MHRA standards

Which medicines can holders of a Wholesale Dealer’s Licence (WL) trade?

• P

• POM

• GSL

• Some herbal medicines

What does quality assurance require manufacturers to maintain?

• Maintaining staff, premises and equipment effectively

• Ensuring safe handling, storage and distribution

• Quality control and qualified persons

• Quality control and qualified persons

• Qualitative and quantitative testing

• Compliance with Good Manufacturing Practice directive (GMP)

What information must appear on medicine labels?

• Product name

• Formulation

• Quantity

• Strength

• Active excipients

• Route of administration

• “Keep out of reach of children”

• Handling and storage conditions

• Expiry date

• Warnings

• Disposal instructions

• Name and address of licence holder

• Batch number

• Instructions on how to take if self medicating

What must blister pack medicines include?

• Product name

• MA holder

• Expiry date

• Batch number

What information must appear on small containers?

• Product name

• Route of administration

• Quantity of product

• Batch number

• Expiry date

What is the purpose of a Patient Information Leaflet (PIL)?

To provide patients with clear, understandable information about a medicine

What must a PIL include?

• Medicine identification

• Therapeutic indications

• Instructions for use

• Side effects

• Emergency advice

• Expiry date reference

• Date of last revision

Who is a PIL and SmPC (Summary of Product Characteristics) written for?

PIL is written for patients whereas SmPC is written for healthcare professionals

Why is a SmPC useful?

For learning and to be used as a reference source

What medicines must be sold under pharmacist supervision?

POM and P medicines

Case laws defining supervision

• Roberts v Littlewoods (1943)

• RPSGB v Boots (1953)

What criteria must be met for a POM to become reclassified as a P medicine?

• Medicine is safe if used correctly or incorrectly

• POM has previously been used safely

• Medicine is not an injection

• Low misuse risk

What is the process for switching POM to P?

• Manufacturer wishing to market POM as P submits all data to MHRA

• MHRA assesses proposed product against a range of standards

• Consultation time to determine whether product is desirable or necessary

• MHRA grants licence if information provided is satisfactory

Why are POM to P switches important?

• Improves access to effective treatments

• Increases pharmacist responsibility

What was the first POM to P switch?

Ibuprofen in 1983

Name examples of major POM to P switches

• Hydrocortisone 1% cream in 1987

• Nicotine gum in 1991

• Topical antifungals in 1992

• Levonorgestrel in 2001

• Omeprazole 10mg in 2004

• Simvastatin 10mg in 2004

What requirements must be met for a P medicine to become GSL?

• No risk to public health

• Medicine is safe to sell without pharmacist supervision

Give an example of a medicine switching from P to GSL?

Aciclovir in 2004 (POM to P in 1993)

What are offences under the HMR 2012?

• Improper use of restricted titles

• Failure to correctly label a medicine

• Sell or supply any medicinal product not of the nature or quality demanded

• Failure to provide an appropriate patient information leaflet

• ‘Loaning’ POM medication

• Purchasing medicines from unlicensed wholesalers

• Sale and supply of certain unlicensed medicines

• Adulteration of medicines

• Failure to identify the responsible pharmacist